Embed Size (px)
Citation preview
Prac%ce'based+Evidence+in+Nutri%on+(PEN®)+www.pennutri%on.com+
is+the+global+resource+for+nutri%on+prac%ce.+
��
Welcome+to+the+PEN®+Evidence'based+Prac%ce+Informa%on+Cycle+Orienta%on+tutorial+
developed+by+PEN®++Global+Team.+++
��
If+you+are+not+very+familiar+with+the+structure+of+PEN®+we+recommend+that+you+
complete+the+5+orienta%on+tutorial+modules+before+con%nuing+with+this+training+
module.+
+
PEN®+Orienta%on+Tutorials+can+be+accessed+at+this+link:+
hIp://www.pennutri%on.com/module_library.aspx+
+
3+
The+framework+we+use+for+crea%ng+PEN®+content+is+the+Evidence'based+Prac%ce+
Informa%on+Cycle.++It+u%lizes+the+5+“A’s”+
• Assess+• Ask+• Acquire+(note+this+says+acquire+the+BEST+evidence,+NOT+all+the+evidence+(an+
important+dis%nc%on)+
• Appraise+• Apply+…and+then+the+cycle+repeats…+++
+
We’re+going+to+walk+through+each+of+the+steps+in+some+detail+with+you.+
4+
5
Assess+is+the+star%ng+point+for+Evidence'based+Diete%c+Prac%ce+
"Evidence'based+prac%ce+starts+with+a+spirit+of+curiosity+within+a+suppor%ve+diete%c+
culture.+++
+
Die%%ans+and+health+care+prac%%oners+can+start+by+regularly+asking+ques%ons+about+
why+they+do+what+they+do.+
6
Developing+what+is+some%mes+called+a+Clinical+Inquiry+Approach+calls+for+
prac%%oners+to+adopt+a+mindset+of+informed+skep%cism.++
+
Detect+issues+and+priori%ze+issues++–+What+is+the+central+concern?+Harm,+prognosis+,+
therapy,+rehabilita%on+
'+What+decisions+are+made+by+whom?++
'+What+is+uncertain?+urgent,+fixable,+frequent,+doable,+interes%ng+
+
The+evidence'based+die%%an+asks+important+and+relevant+ques%ons.++++
What+might+be+done+differently?++What+choices+would+maIer?++
The+focus+here+is+finding+and+evalua%ng+evidence+that+is:+directly+relevant+to+care,+
addresses+knowledge+gaps,+is+vola%le.++
+
Being+driven+by+these+ques%ons,+the+informed+skep%c+goes+to+the+literature+and+is+
able+to+find+evidence+to+answer+the+ques%ons."""The"skills"of"finding"the"evidence"replace"the"expecta8on"that"the"individual"clinician"can"be"all"knowing.+Exper%se+now+lies+in+part+on+being+able+to+find+the+evidence.+We+begin+by+crea%ng+a+searchable+ques%on…++
+
7
The+next+step+in+integra%ng+evidence+into+prac%ce+is+to+convert+informa%on+needs+
from+prac%ce+into+focused,+structured,+searchable+ques%ons.+++
+
With+the+volume+of+scien%fic+literature+today,+the+busy+clinician+doesn't+have+%me+to+
search+through+hundreds+of+ar%cles+to+find+an+answer.++The+goal+in+asking+clinical+
ques%ons+is+to+be+able+to+find+good+quality,+relevant+research+efficiently+that+will+lead+
to+sound+evidence'based+answers+to+resolve+clinical+problems+and+improve+pa%ent+
outcomes.++One+key+to+efficiency+is+asking+a+focused+ques%on.++
++
Ask+–+frame+the+kinds+of+informa%on+you+have+iden%fied+in+Step+1+or+the+ASSESS+
stage+into+searchable+ques%ons.++Taking+%me+to+develop+a+good+ques%on+will+help+you+define+what+to+look+for+and+where+to+look.+%
8
There+are+two+types+of+ques%ons+–+background+ques%ons+and+foreground+ques%ons.%Background"ques%ons+are+oben+of+a+general+nature+and+relate+to+a+condi%on+for+clinical+topics+or+are+about+basic+facts,+descrip%ve+stats+or+regulatory+issues+etc+for+
non'clinical+issues.++Ques%ons+that+pertain+to+a+descrip%on+of+a+disease,+its+e%ology,+
prevalence,+incidence,+course+etc.+would+be+background+ques%ons.+These+are+oben+
ques%ons+asked+by+new+learners.++Answers+can+usually+be+found+in+various+resources+
and+textbooks,+online+sources+such+as+the+Merck+Manual+and+MedlinePlus+
Encyclopedia+and+even+narra%ve+reviews+and+some+original+research+studies+
depending+on+the+topic.+++The+PEN®+Background+documents,+not+surprisingly,+house+
most+of+our+Background+ques%ons.++We+did+this+deliberately+to+make+it+easier+to+find+
informa%on…+you+don’t+have+to+wade+through+background+to+get+to+foreground+
ques%ons…+or+vice+versa+
+
This%training%module%and%the%“PEN®%Asking%the%Ques;on”%module%focus%on%developing%Foreground%ques;ons%%Foreground+ques%ons+generally+relate+to+more+specialized+knowledge+which+address+
issues+of+care,+or+decision+making.+Foreground+ques%ons+usually+ask+about+treatment,+
preven%on,+prognosis+or+diagnosis.++These+are+ques%ons+more+oben+asked+by+experts+
to+address+clinical+or+policy+problems.++We+will+be+focusing+on+asking+and+finding+
answers+to+to+foreground+ques%ons.+++
Here+are+some+credible+online+sources+to+answer+background+ques%ons.+++
! eMedicine+(Medscape)+hIp://emedicine.medscape.com/++
! Mayo+Clinic+hIp://www.mayoclinic.com/++
! Merck+Manual+Online+
hIp://hIp://www.merckmanuals.com/professional/index.html+
! Medline+Plus+Health+Topics+(NLM+and+NIH)+
hIp://www.nlm.nih.gov/medlineplus/healthtopics.html+
! NIDDK+hIp://www2.niddk.nih.gov/++
The+PEN®+Writer’s+Guide+(hIp://www.pennutri%on.com/WriterGuide.aspx)+contains+
a+more+complete+list+and+you+all+likely+have+your+favourites.+++
Any+favourites+you+don’t+see+here+you+can+submit+them+to+us+via+“Contact+Us”+in+PEN®+
and+we+could+certainly+add+them+to+the+list+in+the+PEN®+Writer’s+Guide.+
9+
Use+the+PICO+or+PECO+format+to+formulate+a+searchable+ques%on…+
+
+
10
Your+ques%on+might+have+slightly+different+wording+depending+on+whether+your+
ques%on+relates+to+preven%on+or+e%ology+of+disease+versus+a+treatment+or+
interven%on+type+ques%on.++Different+types+of+ques%ons+are+best+answered+by+
different+types+of+studies+and+we’ll+talk+more+about+that+in+a+moment.+++
+
11
12
Most+inquiries+about+nutri%on+evidence+are+regarding+the+e%ology+or+the+causes+of+
diseases+or+about+op%mizing+health+via+nutri%on.+Examples+of+e%ology+ques%ons+
could+include:+does+vitamin+A+deficiency+cause+night+blindness?,+is+serum+cholesterol+
associated+with+heart+disease?++
+
In+nutri%on,+the+majority+of+studies+are+observa%onal,+in+which+the+inves%gators+
looked+for+associa%ons+between+food+or+nutrient+intakes+and+the+occurrence+of+a+
disease,+to+describe+the+poten%al+e%ology+of+the+disease.++These+studies+usually+
describe+the+direc%on+and+strength+of+associa%on+of+a+par%cular+exposure+with+a+
par%cular+outcome.+Examples+of+observa%onal+studies+include+cohort,+cross'
sec%onal,+and+case+control+studies.+
+
In+comparison,+some+studies+include+an+interven%on,+to+test+a+par%cular+treatment+or+
preven%on+strategy+for+effec%veness+and+the+poten%al+to+cause+harm.+The+best+of+
these+interven%on+studies+are+randomized,+referred+to+as+randomized+controlled+
trials,+and+they+provide+the+most+reliable+form+of+evidence.+
+
When+we+move+to+the+appraisal+sec%on,+you’ll+note+that+different+types+of+studies+
(along+with+things+like+how+consistent+are+the+results+from+study+to+study)+to+
determine+what+leIer+grade+we+give+the+evidence.+++
This+chart+indicates+the+ideal+study+design+for+various+ques%on+types.+It+also+suggests+
what+might+be+some+of+the+appraisal+issues.+
+
If+you+would+like+more+details+and+prac%ce+on+developing+PICO+ques%ons+work+
through+the+“PEN®+Asking+the+Ques%on”+training+module.+If+you+are+OK+with+
developing+PICO+ques%ons+the+next+phase+in+the+evidence'based+prac%ce+informa%on+
cycle+is+the+Acquire+phase.+
13+
14
The+goal+in+searching+is+ideally+to+find+quality+answers+to+your+structured+ques%ons+in+
a+%mely+manner.+++
A+number+of+sources+are+available+that+provide+different+types+and+levels+or+quality+of+
evidence.++
Remember+earlier+on,+we+said+we+are+looking+for+the"BEST"evidence,+usually+not+every+shred+of+evidence+on+a+par%cular+topic.++
+
To+search+efficiently,+the+first+source+that+you+search+should+be+good+pre'appraised+or+
pre'filtered+secondary+sources+that+summarize+the+literature+and+give+you+a+useful+
ac%onable+plan+based+on+the+evidence.++With+these+sources,+the+work+of+finding+and+
cri%cally+appraising+the+literature+has+been+done+for+you.++Pre'filtered+means+that+an+
individual+or+group+of+individuals+with+exper%se+in+a+par%cular+area+have+reviewed+
and+presented+the"methodologically"strongest"data"in"the"field.++We+will+spend+a+bit+
of+%me+looking+at+credible+examples+of+filtered+literature+in+a+moment.++
+
15
So+we+need+to+discover+
What+types+of+evidence+exist?+
How+good+is+the+evidence?+
Where+or+how++do+I+find+the+relevant+evidence?+
The+first+step+in+acquiring+is+searching+the+literature.+You+can+use+the+“Search+Strategy+
Worksheet”+found+in+Appendix+5+of+the+PEN®+Writer’s+Guide+(hIp://
www.pennutri%on.com/WriterGuide.aspx).+A+pdf+of+this+worksheet+can+also+be+found+
on+the+PEN®+website+under+the+link+to+this+training+module:++
hIp://www.pennutri%on.com/resources/PEN_resources/PEN%20Writer%20Training
%20Modules/PENSearchStrategyWorksheet.pdf+
16+
PEN®+has+created+a+Search+Strategy+Worksheet+to+help+guide+your+search+and+
document+your+strategy:
+hIp://www.pennutri%on.com/resources/PEN_resources/PEN%20Writer%20Training
%20Modules/PENSearchStrategyWorksheet.pdf+
+
Review+the+slide+
+
Whether+you+are+taking+a+filtered+literature+approach+or+looking+for+individual+
studies,+you+should+also+document+your+approach+and+the+keywords+you+used.+++
+
Lets+start+by+examining+what+we+mean+by+filtered+literature++
17+
18
In+order+to+sort+through+the+mountain+of+informa%on+in+the+literature,+an+accepted+
prac%ce+is+to+start+with+filtered+literature.++Classified+as+5+�S�s+–+Systems,+Syntheses,+
Summaries,+Synopses+and+Studies.++The+pyramid+reflects+the+numbers+usually+found+
in+these+various+types+of+literature+and+is+not+reflec%ve+of+the+quality+of+evidence.++
Star%ng+at+the+top+with+the+likely+smallest+number+we+have:+
Systems+link+evidence+to+prac%ce+and+can+be+found+in+prac%ce+guidelines.+++
Syntheses+summarize+results+of+many+studies;+use+a+systema%c+process+for+pooling+evidence+from+
mul%ple+studies+to+synthesize+the+informa%on+into+a+systema%c+review+or+meta'analyses+e.g.+
Cochrane+library.++
Summaries+are+regularly+updated+summaries+of+best+evidence+about+clinical+interven%ons;+topics+
generated+by+clinicians+and+presented+as+clinical+ques%ons+e.g.+PEN®++
Synopses+summarize+high+quality+ar%cles+into+brief+synopses.+We+do+not+use+Synopses+to+write+
evidence+statements+but+to+find+studies+to+review.++
If+evidence+can+s%ll+not+be+found+(for+example+the+clinical+issue+involves+a+rare+condi%on+or+needs+
to+be+updated),+then+a+search+in+the+�tradi%onal+literature�+for+individual+Studies+is+necessary.++There+are+many+advantages+to+using+pre'filtered+evidence,+not+the+least+of+which+that+someone+
has+already+reviewed+the+literature+and+chosen+only+methodologies+from+the+strongest+studies+to+
answer+the+research+ques%on.+Even+with+filtered+sources+we+s%ll+look+at+what+has+been+published+
on+the+topic+since+the+filtered+source+of+informa%on+e.g.+if+a+systema%c+review+was+published+6+
months+ago+and+their+literature+search+ended+with+a+date+a+year+prior+to+publica%on+then+we+
need+to+search+the+literature+for+the+past+18+months+to+see+what+has+been+published+since.++
Evidence+statements+in+PEN®+are+usually+composed+of+CPGs,+systema%c+reviews+and+original+
research+studies+–+some+or+all+depending+on+the+topic.++
Let�s+look+at+accessing+the+sources+of+these+5+�S�s+in+more+detail.+++
+
19
The+Na%onal+Guideline+Clearinghouse™+(NGC)+(+hIp://www.guidelines.gov)+
is+a+free+comprehensive+database+of+evidence'based+clinical+prac%ce+guidelines+and+
related+documents.+NGC+is+an+ini%a%ve+of+the+Agency+for+Healthcare+Research+and+
Quality+(AHRQ),+U.S.+Department+of+Health+and+Human+Services.+++
+
We+now+ask+our+PEN®+writers+to+scan+guideline+clearinghouses+in+all+our+partner+
countries…+UK,+AU,+NZ+and+CDN+
NICE,+NHMRC,+ESPEN+etc.++
+
Note:+the+quality+of+clinical+guidelines+need+to+be+assessed+just+like+is+done+for+
systema%c+reviews,+meta'analyses+and+individual+studies.+CPG’s+are+not+necessarily+
beIer+evidence+than+other+sources+of+evidence.+More+on+Clinical+Prac%ce+Guidelines+
later.+
+
Here+you+see+the+World+Wide+Cancer+Research+Fund+Interna%onal+(
hIp://www.wcrf.org/)+and+a+link+to+their+Con%nuous+Update+Project+or+CUPS…++
Ongoing+work,+adding+to+their+systema%c+reviews…+explicit+with+their+search+criteria+
and+their+grading+system+
20+
21
Cochrane+systema%c+reviews+(hIp://www.cochrane.org/cochrane'reviews)+
are+another+example+of+syntheses,+based+on+the+best+available+informa%on+about+
healthcare+interven%ons,+usually+limited+to+randomized+controlled+trials+but+case+
control+and+observa%on+studies+are+reviewed+as+well,+especially+in+public+health+topic+
reviews.+They+explore+the+evidence+for+and+against+the+effec%veness+and+
appropriateness+of+treatments+(medica%ons,+surgery,+educa%on,+etc)+in+specific+
circumstances.+There+are+over+2200+reviews.+Summaries+/+abstracts+are+available+free+
'+the+complete+reviews+are+published+in+The+Cochrane+Library+which+is+available+by+
subscrip%on+though+some+countries+(notably+the+UK+and+Australia),+and+some+
workplaces,+provide+free+access+for+certain+sectors+of+their+popula%ons.++
+
22
A+systema%c+review+is+a+rigorous+systema%c+approach+to+review+of+primary+studies+on+
a+topic.+++
+
The+search+strategies+are+explicit+and+comprehensive+'+the+databases+searched,+the+
dates+included+in+the+search+and+the+selec%on+criteria+for+studies+are+explicitly+
described+(did+the+authors+consider+only+RCTs?+Study+dura%on?).++This+means+that+
anyone+else+conduc%ng+the+review,+would+be+able+to+replicate+the+review.+Cochrane+
reviews+include+a+detailed+methods+sec%on+that+allows+the+reader+to+assess+whether+
the+review+was+done+in+such+a+way+as+to+jus%fy+its+conclusions+–+the+type+of+clinical+
studies+to+be+incorporated+into+a+review+is+carefully+considered,+using+predefined+
criteria;+oben+only+RCTs+are+used.+Risk+of+bias+is+fully+explored.+
If+the+data+collected+in+a+review+are+of+sufficient+quality+and+similar+enough,+they+are+
summarized+sta%s%cally+in+a+meta'analysis,+which+generally+provides+a+beIer+overall+
es%mate+of+a+clinical+effect+than+the+results+from+individual+studies.++
Systema%c+reviews+also+include+a+considera%on+of+the+harms+or+adverse+effects+
associated+with+the+treatment+(or+whether+benefits+outweigh+harms)+and+
occasionally+the+costs+of+treatment+where+this+can+be+determined.++
+
What+dis%nguishes+systema%c+reviews+from+tradi%onal,+narra%ve'type+reviews?++
Read+the+defini%ons+of+systema%c+reviews+and+meta'analysis.+�
���
There+is+generally+a+lot+of+overlap+between+systema%c+reviews+and+meta+analyses.+If+
conduc%ng+a+PubMed+search+one+should+include+both+study+types+as+Limits+for+
searching.+++
+
These+should+not+be+confused+with+narra%ve+reviews….+
24+
Narra%ve+reviews+are+definitely+not+the+same+as+systema%c+reviews+
+
Read+slide+
+
25+
PEN®+itself++is+an+example+of+a+summary+tool:++hIp://www.pennutri%on.com+
It+takes+the+best+evidence+and+summarizes+it+into+graded+prac%ce+guidance.+
Recall+PEN®’+has:+
• Key+prac%ce+points+• Evidence+statements+
• Prac%ce+guidance+summaries+
• Evidence+summaries+
26+
Best+Evidence+and+ACP+Journal+Club+are+examples+of+Synopses+but+both+require+a+
subscrip%on.++
+
The+Trip+Database+'+Taking+Research+into+Prac%ce+(+hIp://www.tripdatabase.com/)+
+is+a+free+tool+that+provides,+among+other+things,+synopses+of+the+evidence+in+
response+to+keywords.++They+also+iden%fy+guidelines,+clinical+trials,+systema%c+reviews+
plus+a+great+deal+more.+The+TRIP+database+helps+to+find+the+literature+but+you+s%ll+
need+to+analyze,+cri%que+and+summarize+the+studies,+guidelines+and+systema%cs+
reviews.+The+Trip+database+can+not+be+cited+as+a+reference+for+evidence.+
+
It+is+medically+focused+though+so+not+all+your+nutri%on+ques%ons+are+likely+to+be+
addressed+in+the+detail+you+might+like+to+see+or+need.++
27+
Depending+on+the+results+of+your+search+of+pre'filtered+literature+you+may+find+your+
answers+without+needing+to+do+a+tradi%onal+literature+search+or+you+may+need+to+do+
a+small+search+of+the+most+recent+literature.+In+some+cases+when+there+is+no+pre'
filtered+literature+this+may+be+the+sole+or+primary+type+of+searching.+PubMed+is+a+free+
tool+for+iden%fying+studies+and+can+also+be+used+to+access+systema%c+reviews:++
www.ncbi.nlm.nih.gov/pubmed/+
++
+
+
28+
If+you+have+iden%fied+a+systema%c+review+that+indicates+the+last+search+date+of+the+
review+authors,+you+could+filter+your+search+of+original+research+to+only+those+studies+
published+aber+that+search+date.+Addi%onally,+you+may+find+addi%onal+studies+that+
you+missed+in+your+original+search+by+paying+aIen%on+to+the+introduc%on+and+
discussion+of+original+research+ar%cles.+Look+to+the+ar%cle’s+bibliography+for+the+
cita%ons.+Be+systema%c+in+your+search+strategies.+++
+
Remember+defining+your+PICO+ques%on+and+searching+are+not+always+mutually+
exclusive.+For+example,+in+searching+you+may+find+in+learning+more+about+your+topic+
that+there+are+more+appropriate+search+terms+for+loca%ng+the+relevant+literature+and+
you+may+need+to+re'search.++
+
If+you+would+like+more+informa%on+on+literature+searching+you+can+complete+the+
“PEN®+PubMed”+training+module.++
29+
Once+you+have+acquired+the+literature+the+second+step+is+to+sib+through+and+see+what+
is+useful+and+what+is+not.+
+
Read+slide+
30
31
Cri%cally+appraising+the+evidence+
Hierarchy+of+Evidence:+to+help+us+understand+that+every+study+is+not+created+equal+and+some+
are+beIer+quality+evidence+than+others.+Some+types+of+studies+are+more+appropriate+
depending+on+the+ques%on+being+asked.++
In+addi%on+to+the+type+or+design+of+the+study,+the+quality+of+the+study+(e.g.+well+designed,+
size,+risk+of+bias…)+is+a+key+component+in+determining+how+it+contributes+to+the+graded+
evidence+used+in+PEN®.+Slides"41"–"47"in+this+training+module+discuss+the+PEN®+grading+system+
and+the+PEN®+Evidence+Grading+Checklist+in+some+detail.+Review+the+“Appraising+the+
Literature”+training+module+for+more+on+assessing+the+quality+of+the+study.+
Depending"on"your"quality"assessment"of"the"document"then,"generally"the"higher"quality"evidence"in"terms"of"design"is"from:"Higher"quality:""Systema%c+reviews+–+to+be+highest+quality+must+be+of+RCTs,+THEN+RCTs++
THEN+SRs+of+nonrandomized+or+cohort+studies+THEN+Cohort+studies+THEN+Case'control+studies+
Lower"quality:"Case+series+or+Case+reports+'+descrip%ons+of+a+single+or+a+series+of+cases+of+some+
illness++
At"the"boLom"are:++Editorials,+expert+opinion+–+not+actually+evidence,+but+opinion+Animal+research+–+studies+conducted+on+animals+cannot+be+applied+directly+to+humans++
In+vitro+'+a+biological+process+conducted+in+a+laboratory+container+i.e.+test+tube+or+petri+dish+
Although+there+are+some+issues/ques%ons+where+animal+and+in+vitro+studies+are+the+most+
appropriate+research+design+,+the+grade+assigned+to+the+resul%ng+KPP+would+s%ll+be+low.++
As+noted+in+PEN’s+grading+checklist;+clinical+impact,+generalizability+and+applicability+also+are+
considered+in+assigning+Grades+A,+B,+C+and+D.+
Note:+(October+1,+2013)+This+is+the+current+hierarchy+of+evidence+but+we+are+aware+of+con%nuing+
discussions+taking+place+within+groups+such+as+Cochrane+and+GRADE+on+grading+hierarchies.+The+PEN®+
team+con%nues+to+monitor+these+discussions.+
+
32+
Read+slides…+in+the+PEN®+training+module:+“Appraising+the+Literature”+we+share+some+
tools+to+evaluate+CPGs…+
33+
Here+is+a+hierarchy+for+appraising+qualita%ve+evidence.++
+
Qualita%ve+studies+use+non'numerical+informa%on,+and+can+provide+valuable+insight+
into+how+people+experience+states+of+health+and+illness+or+how+things+came+about.+
+
Generally+qualita%ve+studies+are+beyond+the+scope+of+this+presenta%on.+However,+in+
case+you+are+assessing+qualita%ve+evidence,+here+is+a+reference+to+a+tool+to+assess+
their+rigor.+Abstract+available+at:+hIp://www.ncbi.nlm.nih.gov/pubmed/17161753+
++++
34+
Read+slide.+If+study+design+is+new+to+you+and+you+would+like+more+informa%on,+
complete+the+“PEN+Quick+Review+of+Study+Designs”+training+module+
35+
Consider+sexng+up+a+Data+Extrac%on+Table.+
+
This+is+a+sample,+you+may+find+that+you+use+more+or+less+categories+depending+on+
your+topic.+++
36+
PEN®+Evidence+Grading+Checklist+is+in+the+PEN®+Writer’s+Guide+
hIp://www.pennutri%on.com/resources/PEN_resources/PEN%20Writer%20Training
%20Modules/PENEvidenceGradingChecklistOct2013.pdf+
User+guides+are+in+PEN®+Writers+Guide+(hIp://www.pennutri%on.com/
WriterGuide.aspx)+
+
and+PDF+documents+of+both+are+linked+just+below+the+link+to+the+“PEN®+Evidence'
based+Process”+training+module+in+PEN®+(hIp://www.pennutri%on.com/
WriterGuide.aspx)+
+
37+
As+an+example,+looking+at+the+Center+for+Health+Evidence+'+User+Guide+for+Therapeu%c+
Interven%on+'+topics+to+consider+in+appraising+your+document….+
+
Are"the"results"valid"–+were+the+subjects+randomized,+were+groups+and+staff+involved+
blinded+to+which+group+they+were+in,+were+the+groups+similar+before+and+throughout+the+
interven%on+in+terms+of+prognos%c+variables+–+those+factors+which+might+give+an+
increased+or+decreased+risk+of+adverse+or+posi%ve+outcomes,+was+follow'up+complete+–+
for+ex:+is+24+weeks+long+enough+to+see+an+effect?+
+
What"are"the"results"–+effect+of+interven%on+/+treatment.+++++
The+confidence+interval+can+be+used+to+look+at+effect+sizes,+since,+based+on+sta%s%cs,+it+
es%mates+the+extreme+values+that+are+likely+to+occur.+
The+p'value+is+used+to+determine+if+the+results+are+sta%s%cally+significant.+
+
How"can"I"apply"the"results"to"my"prac8ce"–+do+your+pa%ents+match+the+study+inclusion+
criteria,+are+there+any+reasons+why+the+results+should+not+apply+to+your+pa%ent,+what+
were+the+primary+and+secondary+endpoints+of+the+study,+what+is+the+number+needed+to+
treat+(NNT)+to+prevent+one+adverse+outcome+or+produce+one+posi%ve+outcome,+is+the+
clinical+endpoint+worth+the+increased+cost+and+risk+of+harm?+++
+
See+PEN®+Writer’s+Guide+–+Appendix+6+for+actual+form:++
hIp://www.pennutri%on.com/WriterGuide.aspx++
+
38+
Similar+to+other+credible+grading+frameworks…+the+PEN®+Grading+system…read+slide+
39
IN+2010+we+compared+the+PEN®+grading+system+with+the+NHMRC+one,+used+in+
Australia,+and+found+tremendous+congruency.++We+actually+tweaked+the+PEN®+one+to+
be+closer+in+line+with+NHMRC+
40+
41
A+number+of+informa%on+sources+were+used+in+developing+a+grading+system+for+PEN.+
Gray+GE+and+Gray+LK.+Evidence'based+medicine:+Applica%ons+in+diete%c+prac%ce.+J+Am+Diet+Assoc+
2002;+102:+1263'1272.++Abstract+available+from:+
hIp://www.ncbi.nlm.nih.gov/pubmed/12792624+
Grandage+KK;+Slawson+DC;+Shaughnessy+AF.+When+less+is+more:+a+prac%cal+approach+to+searching+
for+evidence'based+answers.+J+Med+Libr+Assoc+July+2002;+90(3):+298'2002.+Available+from:+
hIp://www.ncbi.nlm.nih.gov/pubmed/12113514+
Personal+communica%on.+R+Hayward.+Centre+for+Health+Evidence.+2004.++
Canadian+Task+Force+on+Preven%ve+Health+Care.+New+grades+for+recommenda%ons+from+the+
Canadian+Task+Force+of+Preven%ve+Health+Care.+CMAJ.+2003;+169(3):+207'208.+Available+from:++
hIp://www.ncbi.nlm.nih.gov/pubmed/12900479+
Upshur,+REG.+Are+all+evidence'based+prac%ces+alike?+Problems+in+the+ranking+of+evidence.+CMAJ;+
2003;+169(7):672'673.+Available+from:+hIp://www.cmaj.ca/cgi/content/full/169/7/672+
Schüremann+HJ,+Best+D,+Vist+G,+Oxmann+AD+On+behalf+of+the+GRADE+Working+Group.+LeIers,+
numbers,+symbols+and+words:+how+to+communicate+grades+of+evidence+and+
recommenda%ons+CMAJ.+2003;+169(7):677.+Available+from:+
hIp://www.cmaj.ca/cgi/content/full/169/7/677+
+Ebell+MH,+Siwek+J,+Weiss+BD,+Woolf+SH,+Susman+J,+Ewigan+B,+Bowman+M.+SORT:+A+Pa%ent+
Centered+Approach+to+Grading+the+Literature.+Am+Fam+Physician.+2004;+69(3):548'56.+
Available+from:+hIp://www.ncbi.nlm.nih.gov/pubmed/14971837+
GRADE+Working+Group.+Grading+Quality+of+Evidence+and+Strength+of+Recommenda%ons.+BMJ.+
2004;+328:1490.+Available+from:+hIp://bmj.bmjjournals.com/cgi/content/full/328/7454/1490++
+
42
This+slide+and+the+next+3+slides+provide+examples+of+evidence+and+other+factors+to+
consider+in+grading+the+evidence+(this+informa%on+is+drawn+from+the+Evidence+
Grading+Checklist+in+Appendix+2,+p.+25+of+the+PEN+Writer’s+Guide)+
hIp://www.pennutri%on.com/WriterGuide.aspx+
+
43
44
45
Review+the+PEN®+Evidence+Grading+checklist+–+PEN®+Writer’s+Guide+–+Appendix+2+or+
linked+directly+below+this+training+module+on+the+PEN®+database+:+
hIp://www.pennutri%on.com/WriterGuide.aspx++
46+
In+other+words,+our+job+is+to+iden%fy+the+level+of+evidence,+whether+it+is+high+or+low.+
+
For+more+informa%on+on+cri%cally+appraising+the+literature,+we+encourage+you+to+
view+the+“PEN®+Appraising+the+Literature”+training+module+which+contains+links+to+
addi%onal+learning+modules+on+appraisal+as+well+as+an+addi%onal+guideline+for+
appraising+CPG’s.+It+also+walks+you+through+an+appraisal+exercise.+
+
47+
48
Now+the+prac%cal+part+–+applying+what+you+have+found+and+developing+the+key+
prac%ce+point+or+prac%ce+recommenda%on.+Applying+the+evidence+you+have+found+to+
answer+your+ques%on+is+the+basis+of+the+PEN+database+and+requires+a+number+of+
steps+that+we+are+going+to+go+through.+This+is+the+stage+where+the+grade+of+evidence+
is+assigned.+
Keeping+in+mind+these+are+suggested+points+of+how+would+you+might+summarize+the+ar%cle+
into+an+evidence+statement.+The+PEN®+user+should+be+able+to+have+a+snapshot+of+the+ar%cle,+
why+it+has+been+used+to+support+the+key+prac%ce+point+and+how+it+influences+the+grade+of+
evidence+for+the+key+prac%ce+point.++
+
The+evidence+statement+should+not+be+a+re'gurgita%on+of+the+paper’s+abstract.+In+fact,+so+as+
not+to+be+biased+by+how+the+author’s+summarized+the+study+as+they+did+in+their+abstract+you+
may+find+it+helpful+when+wri%ng+your+evidence+statements+to+not+re'read+the+abstract+un%l+
you+are+done+extrac%ng+from+the+full+paper.++++
We+want+to+be+thorough+but+also+concise.+You+will+not+always+have+to+include+inclusion/
exclusion+criteria+in+the+evidence+statement+but+should+be+evalua%ng+these+factors+in+your+
cri%cal+appraisal.+Some%mes+it+can+be+concisely+communicated+in+the+descrip%on+of+the+
popula%on.+Likewise,+the+study+methods+do+not+need+to+be+wriIen+in+extreme+detail+but+they+
should+be+evaluated+in+your+cri%cal+appraisal+for+their+limita%ons+and+appropriateness.+Some+
aspects+of+methods+and+measures+can+be+combined+with+the+sentences+describing+the+
results.+Addi%onally,+you+may+find+that+there+are+results+presented+in+the+study+that+do+not+
pertain+to+your+prac%ce+ques%on,+these+should+not+be+included.+Just+include+the+findings+that+
relate+to+your+topic/ques%on.++
In+addi%on+to+no%ng+the+study+authors’+main+conclusions+and+admiIed+limita%ons,+you+
should+also+note+any+limita%ons+that+you+have+iden%fied+in+your+cri%cal+appraisal+of+the+
study.+To+do+this,+re'insert+the+cita%on+number+to+indicate+that+is+the+end+of+the+informa%on+
provided+by+the+author+and+then+make+your+statements+regarding+conclusions+and+
limita%ons.+See+PEN®+Writers+Guide:+hIp://www.pennutri%on.com/WriterGuide.aspx+
49+
Read+slide+
50+
Taking+all+of+the+evidence+into+considera%on+develop+a+key+prac%ce+point+or+prac%ce+
recommenda%on+that+also+succinctly+summarizes+the+evidence+used.+
+
Read+slide.+
+
When+relevant,+it+is+important+to+consider+risk+versus+benefits+of+a+health+decision+
with+the+client+instead+of+feeling+pressure+to+make+the+decision+in+the+KPP+and+saying+
there+is+not+enough+evidence+to+say+one+should…..+There+are+many+examples+in+
nutri%on+where+the+evidence+is+mixed+or+grey+or+incomplete.+
+
So+a+KPP+conclusion+may+some%mes+be:+“discuss+risks+and+benefits+with+the+client”+
versus+“there+is+not+enough+strong+evidence+to+recommend…..”+
51+
Read+slide.++See+Rheumatoid+Arthri%s+KP+for+more+examples:+
hIp://www.pennutri%on.com/KnowledgePathway.aspx?
kpid=978&pqca%d=144&pqid=976++
+
52+
Not+all+key+prac%ce+points+have+comment+sec%ons.+However,+going+forward+we+
would+like+to+see+writers+make+an+effort+to+include+the+extra+informa%on+they+come+
across+in+their+research+for+the+comments+sec%on.++The+informa%on+in+the+comments+
sec%ons+has+helped+guide+prac%ce+as+it+contains+addi%onal+informa%on+that+informs+
ac%on+but+is+not+necessarily+“gradeable”.+Addi%onally,+the+informa%on+in+the+
comments+sec%ons+is+important+for+the+development+of+prac%ce+guidance+summaries+
and+toolkits.++
53+
Read+and+then+next+slide+for+Example+of+country+partner+differences+
54+
This+is+an+example+of+what+the+Comments+sec%on+might+look+like+if+the+KPP+men%ons:+
It+is+recommended+to+follow+your+country’s+na%onal+healthy+ea%ng+guidelines.+For+
some+of+the+country+specific+links+our+PEN+resource+managers+have+created+
collec%ons+–+like+you+see+in+this+example+and+therefore+only+one+link+is+necessary.++
The+Interna%onal+Healthy+Ea%ng+Guidelines+Collec%on+is+available+from:+
hIp://www.pennutri%on.com/KnowledgePathway.aspx?
kpid=3127&trid=19351&trca%d=27+
+
These+collec%ons+are+clearly+referred+to+the+PEN+Writer’s+Guide+:+
hIp://www.pennutri%on.com/WriterGuide.aspx+
+
+
55+
In+the+PEN®+Writer’s+Guide+(hIp://www.pennutri%on.com/WriterGuide.aspx)+
we+have+a+document+which+gets+updated+as+needed+to+reflect+our+partner+country+
differences.+It+includes+healthy+ea%ng;+dietary+guidance+for+adults,+children+and+
infants….++
56+
Some+KPPs+may+include+a+ra%onale+for+asking+the+ques%on,+if+the+reason+for+asking+it+
isn’t+obvious.+Read+slide+
+
Every+effort+should+be+made+to+include+the+ra%onale+and+proposed+mechanisms+of+
ac%on+in+PEN.+It+is+important+to+be+clear+what+types+of+research/evidence/
observa%on+is+informing+the+proposed+mechanism+of+ac%on.+Is+it+in+vitro?+Human+or+
animal+ex+vivo,+in+vivo?+Observa%onal+or+from+randomized+trials?++Actual+ar%cles+or+a+
narra%ve+or+systema%c+review+that+has+explored+the+mechanism+may+be+cited+for+
this.+Try+to+avoid+relying+just+on+original+research+ar%cles’+introduc%ons+and+
discussions+for+this+material+when+possible.+See+in+PEN+eNews'+ar%cle:+And+Yet+
Another+Thing+About+Bias…+Cita%on+Distor%on.+(August+2013+Vol+3+#3)++
hIp://www.pennutri%on.com/enews.aspx?id=14#172+
++
57+
Here+is+an+example+of+the+Ra%onale+associated+with+the+PEN+ques%on:+Can+the+
inges%on+of+cranberry+products+(juice,+tablets/capsules,+dried+cranberries,+cranberry+
seeds)+prevent+urinary+tract+infec%ons?++This+informa%on+can+be+found+at+the+
following+link:+
+hIp://www.pennutri%on.com/KnowledgePathway.aspx?
kpid=7285&pqca%d=144&pqid=8866&kppid=8867&book=Ra%onale#Ra%onale++
58+
Read+slide+and+of+course,+we+have+a+PEN®+Tool/Resource+Approval+Checklist+++
+'+linked+under+the+link+for+this+training+module:+
hIp://www.pennutri%on.com/WriterGuide.aspx+
+
59+
PEN®+Writers+are+asked+to+iden%fy+and+recommend+tools+that:+
• are+not+already+in+the+PEN®+system+
• agree+with+the+evidence,+no+conflicts+• do+not+have+corporate+sponsorship,+or+if+they+do,+alert+the+PEN®+Tool+and+Resource+
Managers+
• are+for+professionals+and+those+that+are+for+clients++
PEN®+Tool+and+Resource+Managers+
• will+look+at+literacy,+white+space,+print+quality+etc.+
60+
Appendix+18++of+the+PEN®+Writer’s+Guide:+
hIp://www.pennutri%on.com/WriterGuide.aspx+
+
+
Read+slide.+
61+
PEN®+Writer’s+Checklist+is+Appendix+13+in+the+PEN®+Writer’s+Guide+(hIp://
www.pennutri%on.com/WriterGuide.aspx)+and+can+also+be+found+linked+under+this+
training+module+on+the+PEN+website:+
hIp://www.pennutri%on.com/resources/PEN_resources/PEN%20Writer%20Training
%20Modules/PENEvidenceGradingChecklistOct2013.pdf+
+
62+
63+
64+
As+men%oned+previously,+DC+requires+authors+to+assign+IP+ownership+to+DC+allowing+
us+to+hold+the+copyright.+++
65+
While+it+doesn’t+happen+oben,+from+%me'to'%me+we+do+find+some+examples+of+
plagiarism+in+PEN®.+We+do+recognize+that+plagiarism+can+some%mes+be+un'inten%onal.+
To+make+sure+you+are+well+aware+of+all+that+may+be+deemed+plagiarism+and+how+to+
avoid+it+see+the+guidelines+we+have+developed+'+Appendix+11+of+the+PEN®+Writer’s+
Guide.++To+access+the+PEN+eNews+ar%cle:++“The+“P”+word….+And+we+don’t+mean+PEN”++
go+to:++hIp://www.pennutri%on.com/enews.aspx?id=6+
-
66+
The+other+PEN®+Writer+training+modules+can+be+accessed+at:++
hIp://www.pennutri%on.com/WriterGuide.aspx+
+
���
68+
69+
